Amendment to Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19, 21012-21014 [2020-08040]
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Federal Register / Vol. 85, No. 73 / Wednesday, April 15, 2020 / Notices
document entitled, ‘‘Agency
Information Collection Activities:
Proposed Collection; Comment
Request’’. That notice invited public
comments on five separate information
collection requests, under Document
Identifiers: CMS–10468, CMS–10418,
CMS–10488, CMS–R–290, and CMS–
10525. Through the publication of this
document, we are withdrawing the
portion of the notice requesting public
comment on the information collection
request titled, ‘‘PACE Quality Data
Monitoring and Reporting.’’ Form
number: CMS–10525 (OMB control
number: 0938–1264).
The original comment period for
the document that published on March
24, 2020, remains in effect and ends
May 26, 2020.
DATES:
In FR
document, 2020–06077, published on
March 24, 2020 (85 FR 16631), we are
withdrawing item 6 ‘‘PACE Quality Data
Monitoring and Reporting’’ which
begins on page 16633.
SUPPLEMENTARY INFORMATION:
Dated: April 9, 2020.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2020–07886 Filed 4–14–20; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Intergovernmental Reference Guide
(IRG) OMB #0970–0209
Office of Child Support
Enforcement; Administration for
Children and Families; HHS
ACTION: Request for public comment.
AGENCY:
The Intergovernmental
Reference Guide (IRG) is a centralized
and automated repository of state and
tribal profiles that contains high-level
descriptions of each state and tribal
child support enforcement (CSE)
program. These profiles provide state,
tribal, and foreign country CSE agencies
with an effective and efficient method
for updating and accessing information
needed to process intergovernmental
child support cases.
DATES: Comments due within 30 days of
publication. The Office of Management
and Budget (OMB) is required to make
a decision concerning the collection of
information between 30 and 60 days
after publication of this document in the
Federal Register. Therefore, a comment
is best assured of having its full effect
if OMB receives it within 30 days of
publication.
ADDRESSES: Written comments and
recommendations for the proposed
SUMMARY:
information collection should be sent
directly to the following: Office of
Management and Budget, Paperwork
Reduction Project, Email: OIRA_
SUBMISSION@OMB.EOP.GOV, Attn:
Desk Officer for the Administration for
Children and Families.
Copies of the proposed collection may
be obtained by emailing infocollection@
acf.hhs.gov. Alternatively, copies can
also be obtained by writing to the
Administration for Children and
Families, Office of Planning, Research
and Evaluation, 330 C Street SW,
Washington, DC 20201, Attn: ACF
Reports Clearance Officer. All requests,
emailed or written, should be identified
by the title of the information collection.
SUPPLEMENTARY INFORMATION:
Description: The Office of Child
Support Enforcement (OCSE) is
proposing to add a new section (Section
O) with six questions pertaining to
family violence in the state profile. This
will help process intergovernmental
cases with family violence and will help
ensure the safety of children and
families. OCSE is also proposing to
delete Sections A–L (140 questions)
from the tribal profile and create new
sections (Sections A–D) with 11
questions regarding case processing.
This will assist in the efficient
processing of paternity and support
obligations.
Respondents: State and tribal CSE
agencies.
ANNUAL BURDEN ESTIMATES
Total
number of
respondents
Information collection instrument
jbell on DSKJLSW7X2PROD with NOTICES
IRG: State Profile Guide (states and territories) .................................................
IRG: Tribal Profile Guide .....................................................................................
Estimated Total Annual Burden
Hours: 627.
Authority for the IRG information
collection activities is: (1) 42 U.S.C.
652(a)(7), which requires the federal
OCSE to provide technical assistance to
state child support enforcement
agencies to help them establish effective
systems for collecting child and spousal
support; (2) 42 U.S.C. 666(f), which
requires states to enact the Uniform
Interstate Family Support Act; (3) 45
CFR. 301.1, which defines an
intergovernmental case to include cases
between states and tribes; (4) 45 CFR.
303.7, which requires state CSE agencies
to provide services in intergovernmental
cases; and (5) 45 CFR. 309.120, which
requires a tribal child support program
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18:22 Apr 14, 2020
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54
62
to include intergovernmental
procedures in its tribal IV–D plan.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2020–07885 Filed 4–14–20; 8:45 am]
BILLING CODE 4184–41–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Amendment to Declaration Under the
Public Readiness and Emergency
Preparedness Act for Medical
Countermeasures Against COVID–19
ACTION:
PO 00000
Notice of amendment.
Frm 00039
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Number of
responses per
respondent
18
18
Average
burden hour
per response
Annual
burden
hours
0.3
0.3
292
335
The Secretary is issuing this
amendment pursuant to section 319F–3
of the Public Health Service Act to
extend liability immunity for activities
related to medical countermeasures
against COVID–19 authorized under the
Coronavirus Aid, Relief, and Economic
Security Act.
SUMMARY:
The amendment to the
Declaration published on March 17,
2020 (85 FR 15198) was effective as of
March 27, 2020.
DATES:
FOR FURTHER INFORMATION CONTACT:
Robert P. Kadlec, MD, MTM&H, MS,
Assistant Secretary for Preparedness
and Response, Office of the Secretary,
Department of Health and Human
Services, 200 Independence Avenue
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15APN1
jbell on DSKJLSW7X2PROD with NOTICES
Federal Register / Vol. 85, No. 73 / Wednesday, April 15, 2020 / Notices
SW, Washington, DC 20201; Telephone:
202–205–2882.
SUPPLEMENTARY INFORMATION: The
Public Readiness and Emergency
Preparedness Act (PREP Act) authorizes
the Secretary of Health and Human
Services (the Secretary) to issue a
Declaration to provide liability
immunity to certain individuals and
entities (Covered Persons) against any
claim of loss caused by, arising out of,
relating to, or resulting from the
manufacture, distribution,
administration, or use of medical
countermeasures (Covered
Countermeasures), except for claims
involving ‘‘willful misconduct’’ as
defined in the PREP Act. Under the
PREP Act, a Declaration may be
amended as circumstances warrant.
The PREP Act was enacted on
December 30, 2005, as Public Law 109–
148, Division C, Section 2. It amended
the Public Health Service (PHS) Act,
adding Section 319F–3, which
addresses liability immunity, and
Section 319F–4, which creates a
compensation program. These sections
are codified at 42 U.S.C. 247d–6d and
42 U.S.C. 247d–6e, respectively. The
Coronavirus Aid, Relief, and Economic
Security (CARES) Act, Public Law 116–
136 was enacted on March 27, 2020.
The CARES Act amended section 319F–
3(i)(1)(D) of the PHS Act, first added by
the Families First Coronavirus Response
Act, Public Law 116–127 on March 18,
2020. These amendments created a new
category of covered countermeasures
eligible for liability immunity under the
PREP Act, namely, respiratory
protective devices approved by the
National Institute for Occupational
Safety and Health (NIOSH) under 42
CFR part 84, or any successor
regulations, that the Secretary
determines to be a priority for use
during a public health emergency
declared under section 319 of the PHS
Act.
On January 31, 2020, the Secretary
declared a public health emergency,
pursuant to section 319 of the PHS Act,
42 U.S.C. 247d, for the entire United
States to aid in the response of the
nation’s health care community to the
COVID–19 outbreak. On March 10,
2020, the Secretary issued a Declaration
under the PREP Act for medical
countermeasures against COVID–19 (85
FR 15198 (March 17, 2020)). The
Secretary is amending the March 10,
2020 Declaration under the PREP Act to
extend liability immunity to covered
countermeasures authorized under the
CARES Act. This amendment is made in
accordance with section 319F–3 of the
PHS Act, which authorizes the Secretary
VerDate Sep<11>2014
18:22 Apr 14, 2020
Jkt 250001
to amend a PREP Act declaration at any
time.
Description of This Amendment by
Section
Section I. Determination of Public
Health Emergency or Credible Risk of
Future Public Health Emergency
Before issuing a Declaration under the
PREP Act, the Secretary is required to
determine that a disease or other health
condition or threat to health constitutes
a public health emergency or that there
is a credible risk that the disease,
condition, or threat may constitute such
an emergency. This determination is
separate and apart from the Declaration
issued by the Secretary on January 31,
2020 under section 319 of the PHS Act
that a disease or disorder presents a
public health emergency or that a public
health emergency, including significant
outbreaks of infectious diseases or
bioterrorist attacks, otherwise exists, or
other Declarations or determinations
made under other authorities of the
Secretary. As amended by the CARES
Act, to extend the Declaration to
respiratory protective devices approved
by NIOSH, the Secretary must also
determine that a respiratory protective
device approved by NIOSH under 42
CFR part 84, or any successor
regulations, is a priority for use during
the public health emergency declared by
the Secretary under section 319 of the
PHS Act.
Accordingly, in Section I of the
Declaration, the Secretary is amending
his determination that the spread of
SARS–CoV–2 or a virus mutating
therefrom and the resulting disease,
COVID–19, constitutes a public health
emergency for purposes of this
Declaration under the PREP Act to
include the determination that the use
of any respiratory protective devices
approved by NIOSH under 42 CFR part
84, or any successor regulations, is a
priority for use during the public health
emergency declared by the Secretary on
January 31, 2020 under section 319 of
the PHS Act for the entire United States
to aid in the nation’s health care
community response to the COVID–19
outbreak.
Section VI. Covered Countermeasures
Section VI of the Declaration
identifies the Covered Countermeasures
for which the Secretary has
recommended such activities. As
amended by the CARES Act, the PREP
Act states that a ‘‘Covered
Countermeasure’’ must be a ‘‘qualified
pandemic or epidemic product,’’ a
‘‘security countermeasure,’’ a drug,
biological product, or device authorized
PO 00000
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21013
for emergency use in accordance with
sections 564, 564A, or 564B of the
Federal Food, Drug, and Cosmetic
(FD&C) Act, or a respiratory protective
device approved by NIOSH under 42
CFR part 84, or any successor
regulations, that the Secretary
determines to be a priority for use
during a public health emergency
declared under section 319 of the PHS
Act. Accordingly, in Section VI of the
Declaration, the Secretary is amending
the list of medical countermeasures
against COVID–19 that are covered
countermeasures under the declaration
to include covered countermeasures
authorized by the CARES Act, namely
respiratory protective devices approved
by NIOSH under 42 CFR part 84, or any
successor regulations, that the Secretary
determines to be a priority for use
during a public health emergency
declared under section 319 of the PHS
Act.
Section XII. Effective Time Period
The Secretary must identify, for each
Covered Countermeasure, the period or
periods during which liability immunity
is in effect, designated by dates,
milestones, or other description of
events, including factors specified in the
PREP Act. Accordingly, the Secretary is
amending Section XII of the Declaration
to specify the effective time period for
covered countermeasures authorized by
the CARES Act.
Amendments to Declaration
Amended Declaration for Public
Readiness and Emergency Preparedness
Act Coverage for medical
countermeasures against COVID–19.
Sections I, VI and XII of the March 10,
2020, Declaration under the PREP Act
for medical countermeasures against
COVID–19 are amended pursuant to
section 319F–3(b)(4) of the PHS Act as
described below. All other Sections of
the Declaration remain in effect as
published at 85 FR 15198 (March 17,
2020).
1. Determination of Public Health
Emergency, Section I: Delete in full and
replace with:
I. Determination of Public Health
Emergency
42 U.S.C. 247d–6d(b)(1)
I have determined that the spread of
SARS–CoV–2 or a virus mutating
therefrom and the resulting disease
COVID–19 constitutes a public health
emergency. I further determine that use
of any respiratory protective device
approved by NIOSH under 42 CFR part
84, or any successor regulations, is a
priority for use during the public health
emergency that I declared on January
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21014
Federal Register / Vol. 85, No. 73 / Wednesday, April 15, 2020 / Notices
31, 2020 under section 319 of the PHS
Act for the entire United States to aid in
the response of the nation’s health care
community to the COVID–19 outbreak.
2. Covered Countermeasures, Section
VI, delete in full and replace with:
jbell on DSKJLSW7X2PROD with NOTICES
VI. Covered Countermeasures
42 U.S.C. 247d–6b(c)(1)(B), 42 U.S.C.
247d–6d(i)(1) and (7)
Covered Countermeasures are any
antiviral, any other drug, any biologic,
any diagnostic, any other device, any
respiratory protective device, or any
vaccine, used to treat, diagnose, cure,
prevent, or mitigate COVID–19, or the
transmission of SARS–CoV–2 or a virus
mutating therefrom, or any device used
in the administration of any such
product, and all components and
constituent materials of any such
product.
Covered Countermeasures must be
‘‘qualified pandemic or epidemic
products,’’ or ‘‘security
countermeasures,’’ or drugs, biological
products, or devices authorized for
investigational or emergency use, as
those terms are defined in the PREP Act,
the FD&C Act, and the Public Health
Service Act, or any respiratory
protective device approved by NIOSH
under 42 CFR part 84, or any successor
regulations.
3. Effective Time Period, Section XII,
delete in full and replace with:
XII. Effective Time Period
42 U.S.C. 247d–6d(b)(2)(B)
Liability immunity for any respiratory
protective device approved by NIOSH
under 42 CFR part 84, or any successor
regulations, through means of
distribution, as identified in Section
VII(a) of this Declaration, other than in
accordance with the public health and
medical response of the Authority
Having Jurisdiction, begins on March
27, 2020 and extends through October 1,
2024.
Liability immunity for all other
Covered Countermeasures identified in
Section VI of this Declaration, through
means of distribution, as identified in
Section VII(a) of this Declaration, other
than in accordance with the public
health and medical response of the
Authority Having Jurisdiction, begins
February 4, 2020 and extends through
October 1, 2024.
Liability immunity for all Covered
Countermeasures administered and
used in accordance with the public
health and medical response of the
Authority Having Jurisdiction begins
with an emergency declaration and lasts
through (1) the final day the emergency
Declaration is in effect, or (2) October 1,
2024, whichever occurs first.
VerDate Sep<11>2014
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Authority: 42 U.S.C. 247d–6d.
Dated: April 10, 2020.
Alex M. Azar II,
Secretary of Health and Human Services.
[FR Doc. 2020–08040 Filed 4–13–20; 4:15 pm]
Dated: April 9, 2020.
Tyeshia M. Roberson,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2020–07917 Filed 4–14–20; 8:45 am]
BILLING CODE 4140–01–P
BILLING CODE 4150–28–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institutes of Health
National Institute of Environmental
Health Sciences; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Environmental Health Sciences Special
Emphasis Panel: Mechanism for Time
Sensitive Research Opportunities in
Environmental Health Sciences.
Date: April 30, 2020.
Time: 11:00 a.m. to 1:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Environmental
Health Sciences, National Institutes of
Health, Keystone Building, 530 Davis Drive,
Research Triangle Park, NC 27709 (Virtual
Meeting).
Contact Person: Janice B Allen, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, Division of Extramural Research and
Training, Nat. Institute of Environmental
Health Science, P. O. Box 12233, MD EC–30/
Room 3170 B, Research Triangle Park, NC
27709 919–541–7556.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.115, Biometry and Risk
Estimation—Health Risks from
Environmental Exposures; 93.142, NIEHS
Hazardous Waste Worker Health and Safety
Training; 93.143, NIEHS Superfund
Hazardous Substances—Basic Research and
Education; 93.894, Resources and Manpower
Development in the Environmental Health
Sciences; 93.113, Biological Response to
Environmental Health Hazards; 93.114,
Applied Toxicological Research and Testing,
National Institutes of Health, HHS)
PO 00000
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel RFA–RM–
20–006: 4DN Organization and Function in
Human Health and Disease, New
Investigators (U01).
Date: May 14, 2020.
Time: 9:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892, (Virtual Meeting).
Contact Person: Jessica Smith, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD
20892, (301) 402–3717, jessica.smith6@
nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel RFA–RM–
20–005: 4DN Organization and Function in
Human Health and Disease (U01).
Date: May 14–15, 2020.
Time: 1:00 p.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892, (Virtual Meeting).
Contact Person: Jessica Smith, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD
20892, (301) 402–3717, jessica.smith6@
nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
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]]>Agencies
[Federal Register Volume 85, Number 73 (Wednesday, April 15, 2020)]
[Notices]
[Pages 21012-21014]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-08040]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
Amendment to Declaration Under the Public Readiness and Emergency
Preparedness Act for Medical Countermeasures Against COVID-19
ACTION: Notice of amendment.
-----------------------------------------------------------------------
SUMMARY: The Secretary is issuing this amendment pursuant to section
319F-3 of the Public Health Service Act to extend liability immunity
for activities related to medical countermeasures against COVID-19
authorized under the Coronavirus Aid, Relief, and Economic Security
Act.
DATES: The amendment to the Declaration published on March 17, 2020 (85
FR 15198) was effective as of March 27, 2020.
FOR FURTHER INFORMATION CONTACT: Robert P. Kadlec, MD, MTM&H, MS,
Assistant Secretary for Preparedness and Response, Office of the
Secretary, Department of Health and Human Services, 200 Independence
Avenue
[[Page 21013]]
SW, Washington, DC 20201; Telephone: 202-205-2882.
SUPPLEMENTARY INFORMATION: The Public Readiness and Emergency
Preparedness Act (PREP Act) authorizes the Secretary of Health and
Human Services (the Secretary) to issue a Declaration to provide
liability immunity to certain individuals and entities (Covered
Persons) against any claim of loss caused by, arising out of, relating
to, or resulting from the manufacture, distribution, administration, or
use of medical countermeasures (Covered Countermeasures), except for
claims involving ``willful misconduct'' as defined in the PREP Act.
Under the PREP Act, a Declaration may be amended as circumstances
warrant.
The PREP Act was enacted on December 30, 2005, as Public Law 109-
148, Division C, Section 2. It amended the Public Health Service (PHS)
Act, adding Section 319F-3, which addresses liability immunity, and
Section 319F-4, which creates a compensation program. These sections
are codified at 42 U.S.C. 247d-6d and 42 U.S.C. 247d-6e, respectively.
The Coronavirus Aid, Relief, and Economic Security (CARES) Act, Public
Law 116-136 was enacted on March 27, 2020. The CARES Act amended
section 319F-3(i)(1)(D) of the PHS Act, first added by the Families
First Coronavirus Response Act, Public Law 116-127 on March 18, 2020.
These amendments created a new category of covered countermeasures
eligible for liability immunity under the PREP Act, namely, respiratory
protective devices approved by the National Institute for Occupational
Safety and Health (NIOSH) under 42 CFR part 84, or any successor
regulations, that the Secretary determines to be a priority for use
during a public health emergency declared under section 319 of the PHS
Act.
On January 31, 2020, the Secretary declared a public health
emergency, pursuant to section 319 of the PHS Act, 42 U.S.C. 247d, for
the entire United States to aid in the response of the nation's health
care community to the COVID-19 outbreak. On March 10, 2020, the
Secretary issued a Declaration under the PREP Act for medical
countermeasures against COVID-19 (85 FR 15198 (March 17, 2020)). The
Secretary is amending the March 10, 2020 Declaration under the PREP Act
to extend liability immunity to covered countermeasures authorized
under the CARES Act. This amendment is made in accordance with section
319F-3 of the PHS Act, which authorizes the Secretary to amend a PREP
Act declaration at any time.
Description of This Amendment by Section
Section I. Determination of Public Health Emergency or Credible Risk of
Future Public Health Emergency
Before issuing a Declaration under the PREP Act, the Secretary is
required to determine that a disease or other health condition or
threat to health constitutes a public health emergency or that there is
a credible risk that the disease, condition, or threat may constitute
such an emergency. This determination is separate and apart from the
Declaration issued by the Secretary on January 31, 2020 under section
319 of the PHS Act that a disease or disorder presents a public health
emergency or that a public health emergency, including significant
outbreaks of infectious diseases or bioterrorist attacks, otherwise
exists, or other Declarations or determinations made under other
authorities of the Secretary. As amended by the CARES Act, to extend
the Declaration to respiratory protective devices approved by NIOSH,
the Secretary must also determine that a respiratory protective device
approved by NIOSH under 42 CFR part 84, or any successor regulations,
is a priority for use during the public health emergency declared by
the Secretary under section 319 of the PHS Act.
Accordingly, in Section I of the Declaration, the Secretary is
amending his determination that the spread of SARS-CoV-2 or a virus
mutating therefrom and the resulting disease, COVID-19, constitutes a
public health emergency for purposes of this Declaration under the PREP
Act to include the determination that the use of any respiratory
protective devices approved by NIOSH under 42 CFR part 84, or any
successor regulations, is a priority for use during the public health
emergency declared by the Secretary on January 31, 2020 under section
319 of the PHS Act for the entire United States to aid in the nation's
health care community response to the COVID-19 outbreak.
Section VI. Covered Countermeasures
Section VI of the Declaration identifies the Covered
Countermeasures for which the Secretary has recommended such
activities. As amended by the CARES Act, the PREP Act states that a
``Covered Countermeasure'' must be a ``qualified pandemic or epidemic
product,'' a ``security countermeasure,'' a drug, biological product,
or device authorized for emergency use in accordance with sections 564,
564A, or 564B of the Federal Food, Drug, and Cosmetic (FD&C) Act, or a
respiratory protective device approved by NIOSH under 42 CFR part 84,
or any successor regulations, that the Secretary determines to be a
priority for use during a public health emergency declared under
section 319 of the PHS Act. Accordingly, in Section VI of the
Declaration, the Secretary is amending the list of medical
countermeasures against COVID-19 that are covered countermeasures under
the declaration to include covered countermeasures authorized by the
CARES Act, namely respiratory protective devices approved by NIOSH
under 42 CFR part 84, or any successor regulations, that the Secretary
determines to be a priority for use during a public health emergency
declared under section 319 of the PHS Act.
Section XII. Effective Time Period
The Secretary must identify, for each Covered Countermeasure, the
period or periods during which liability immunity is in effect,
designated by dates, milestones, or other description of events,
including factors specified in the PREP Act. Accordingly, the Secretary
is amending Section XII of the Declaration to specify the effective
time period for covered countermeasures authorized by the CARES Act.
Amendments to Declaration
Amended Declaration for Public Readiness and Emergency Preparedness
Act Coverage for medical countermeasures against COVID-19.
Sections I, VI and XII of the March 10, 2020, Declaration under the
PREP Act for medical countermeasures against COVID-19 are amended
pursuant to section 319F-3(b)(4) of the PHS Act as described below. All
other Sections of the Declaration remain in effect as published at 85
FR 15198 (March 17, 2020).
1. Determination of Public Health Emergency, Section I: Delete in
full and replace with:
I. Determination of Public Health Emergency
42 U.S.C. 247d-6d(b)(1)
I have determined that the spread of SARS-CoV-2 or a virus mutating
therefrom and the resulting disease COVID-19 constitutes a public
health emergency. I further determine that use of any respiratory
protective device approved by NIOSH under 42 CFR part 84, or any
successor regulations, is a priority for use during the public health
emergency that I declared on January
[[Page 21014]]
31, 2020 under section 319 of the PHS Act for the entire United States
to aid in the response of the nation's health care community to the
COVID-19 outbreak.
2. Covered Countermeasures, Section VI, delete in full and replace
with:
VI. Covered Countermeasures
42 U.S.C. 247d-6b(c)(1)(B), 42 U.S.C. 247d-6d(i)(1) and (7)
Covered Countermeasures are any antiviral, any other drug, any
biologic, any diagnostic, any other device, any respiratory protective
device, or any vaccine, used to treat, diagnose, cure, prevent, or
mitigate COVID-19, or the transmission of SARS-CoV-2 or a virus
mutating therefrom, or any device used in the administration of any
such product, and all components and constituent materials of any such
product.
Covered Countermeasures must be ``qualified pandemic or epidemic
products,'' or ``security countermeasures,'' or drugs, biological
products, or devices authorized for investigational or emergency use,
as those terms are defined in the PREP Act, the FD&C Act, and the
Public Health Service Act, or any respiratory protective device
approved by NIOSH under 42 CFR part 84, or any successor regulations.
3. Effective Time Period, Section XII, delete in full and replace
with:
XII. Effective Time Period
42 U.S.C. 247d-6d(b)(2)(B)
Liability immunity for any respiratory protective device approved
by NIOSH under 42 CFR part 84, or any successor regulations, through
means of distribution, as identified in Section VII(a) of this
Declaration, other than in accordance with the public health and
medical response of the Authority Having Jurisdiction, begins on March
27, 2020 and extends through October 1, 2024.
Liability immunity for all other Covered Countermeasures identified
in Section VI of this Declaration, through means of distribution, as
identified in Section VII(a) of this Declaration, other than in
accordance with the public health and medical response of the Authority
Having Jurisdiction, begins February 4, 2020 and extends through
October 1, 2024.
Liability immunity for all Covered Countermeasures administered and
used in accordance with the public health and medical response of the
Authority Having Jurisdiction begins with an emergency declaration and
lasts through (1) the final day the emergency Declaration is in effect,
or (2) October 1, 2024, whichever occurs first.
Authority: 42 U.S.C. 247d-6d.
Dated: April 10, 2020.
Alex M. Azar II,
Secretary of Health and Human Services.
[FR Doc. 2020-08040 Filed 4-13-20; 4:15 pm]
BILLING CODE 4150-28-P
